Adjuvanted subunit vaccine offers long-lasting protection

The results of ZOSTER-049 – an extension of two Phase III clinical trials – show that the adjuvanted recombinant zoster vaccine (RZV) can provide protection against shingles for a decade in adults over 50 years of age. The RZV vaccination has now been included in many national vaccination plans, so that a large database is now available.

The Swiss vaccination plan recommends the adjuvanted subunit vaccine Shingrix®recommended for immunocompetent persons aged 65 and over or in case of immunodeficiency aged 50 and over [1,2]. Two doses at two-month intervals are usually required for basic immunization. The costs are covered by compulsory health insurance.

Worldwide, up to 1 in 3 people develop shingles in the course of their lives [3,8–11]. With increasing age, the immune system’s resistance to the infection decreases, which increases the risk of contracting shingles [8]. Other factors that increase the risk are immunodeficiency or immunosuppression, as well as other chronic diseases such as COPD, diabetes and asthma [12]. Postherpetic neuralgia (PHN) is the most common complication of shingles and, according to the results of various studies, occurs in 5-30% of all cases, with the risk increasing in line with age [13,14].

ZOSTER-049: Follow-up period from 6-11 years

The open-label, multi-center, multi-country, long-term follow-up study ZOSTER-049 built on the two randomized Phase III pivotal clinical trials ZOE-50 and ZOE-70 and investigated efficacy, safety and immunogenicity in adults aged ≥50 years at the time of vaccination [3]. Over 7000 people from 18 countries on five continents took part in ZOSTER-049. Recently published data show that the recombinant zoster vaccine (RZV) remains effective against shingles for more than a decade in adults over 50 years of age**:

The primary endpoint focused on the cumulative efficacy of the vaccine (Vaccine Efficacy, VE) in the period from the 6th to the 11th year after vaccination. In adults aged ≥50 years, a VE of 79.7% was observed (95% CI: 73.7-84.6) [4].
VE in adults ≥50 remained high in every single year after the initial vaccination (two doses) in ZOE-50 and ZOE-70, with VE in the 11th and final year at 82.0% (95% CI: 63.0-92.2) [4].
High VE rates were observed in all age groups over 50 years, including the group aged ≥70 years, who had a cumulative VE of 73.1% between six and eleven years after vaccination (95% CI: 62.9-80.9).
No new safety concerns were identified during the observation period [4]. In ≥50-year-olds, the most frequently reported side effects of the recombinant zoster vaccine are pain at the injection site, myalgia, fatigue and headache. Most of these reactions were of mild to moderate intensity and generally lasted less than three days [5].

** The effectiveness of the vaccination was observed in some participants up to the advanced age of 80 and 90 years.

“These final data show that the recombinant zoster vaccine provides sustained protection for more than a decade and remains highly effective in both the 50+ and 70+ age groups. Infectious diseases such as shingles pose a significant risk to adults due to the natural decline of our immune system, and these data are a remarkable advance in our understanding of what can be achieved for effective long-term protection against shingles,” said Dr. Javier Díez-Domingo, Principal Investigator, Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain [3].

Shingrix®
This zoster vaccine/RZV is a non-live, recombinant subunit vaccine that can be used to prevent shingles in adults aged 50 years and older [3]. It combines an antigen (glycoprotein E) with an adjuvant system (AS01B) and can counteract the natural age-related decline in the immune response [6,7]. RZV is not indicated for the prevention of primary varicella infection (chickenpox). Shingrix® should be used in accordance with the official vaccination recommendations and the Information for healthcare professionals.

Source: GSK

Literature:

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«Neue Langzeitdaten zeigen, dass Shingrix bei Erwachsenen ab 50 Jahren mehr als ein Jahrzehnt lang einen hohen Schutz gegen Gürtelrose bietet», GSK, 17.04.2024.
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The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc.(NASDAQ: AGEN), MPL and liposomes. (NASDAQ: AGEN), MPL and liposomes.
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